Analysis of Imaging Features From Patients Treated With Brolucizumab in the Post-marketing Setting With Reports of Retinal Vasculitis and/or Retinal Vascular Occlusion

Novartis

Status: Completed

Conditions: Intraocular Inflammation; Retinal Vascular Occlusion

Treatments: Other: Brolucizumab

Study type: Observational

Funder types: Industry

Identifiers

NCT05657158

CRTH258A2404

Details and patient eligibility

About

This non-interventional descriptive study was undertaken to better understand the most common imaging features associated with inflammation arising in the post-marketing setting when brolucizumab was prescribed in routine clinical practice.

Full description

The purpose of this retrospective study analysis was to better characterize the risk of inflammatory events arising from use of brolucizumab in routine clinical practice through analysis of independently reviewed ocular imaging data obtained from cases with reports of intraocular inflammation (IOI), retinal vasculitis (RV) and/or Retinal vascular occlusion (RO) and to provide a description of these features.

Whenever an AE report pertaining to RV and/or RO was reported to Novartis Patient Safety, a follow-up check list (targeted follow-up checklists [TFUs]) was sent by Novartis to the reporter. The reporter was encouraged to share all available images obtained as part of clinical practice, irrespective of the timing or event (i.e. images before, during, and after event could be provided). The focus and main efforts of this data collection was on adverse events of RV and/or RO; for other IOI only events, the images were not actively requested in the case documentation process, however in some cases these were spontaneously reported by the reporter.

All images obtained from Feb 2020 up to 31 Jan 2021 were reviewed in a standardized manner by an external reading center. Dedicated grading lists were developed for each of the image modalities: Fluorescein Angiography (FA), Fundus Photography (FP), Indocyanine Green Angiography (ICGA), Optical Coherence Tomography (OCT), and OCT Angiography (OCT-A).

Enrollment: 198 patients

Sex: All

Ages: 18 to 105 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• participants with cases of RV and/or RO reported to Novartis Patient Safety following brolucizumab use in routine clinical practice for which images were provided to Novartis and read by the Reading Centre

Trial design

198 participants in 1 patient group

Brolucizumab

Description:

brolucizumab in routine clinical practice

Treatment:

Other: Brolucizumab